FDA Orange Book · active-ingredient family
Erythromycin stearate
Erythromycin stearate: 0 brands, 15 generics; first approved May 15, 1990; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 15 ANDA applications approved.
Brands (NDA)
0
Generics (ANDA)
15
Listed patents
0
Presentations
25
Generic (ANDA) products (15)
Abbreviated applications
- ERYTHROMYCIN STEARATEANI PHARMSANDA 0631791990
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Discontinued — - BRISTOLANDA 061304—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — - BRISTOLANDA 061887—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — - PARKE DAVISANDA 062032—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — - WARNER CHILCOTTANDA 062322—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — - AZURITYANDA 060359—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 125MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — - ERYTHROMYCIN STEARATEANI PHARMSANDA 061461—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — - ERYTHROMYCIN STEARATEANI PHARMSANDA 061591—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — - ERYTHROMYCIN STEARATELEDERLEANDA 062089—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — - ERYTHROMYCIN STEARATEPHARMOBEDIENTANDA 061505—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — - ERYTHROMYCIN STEARATEPUREPAC PHARMANDA 061743—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — - ERYTHROMYCIN STEARATEWATSON LABSANDA 062121—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET ORAL Discontinued — EQ 250MG BASE TABLET ORAL Discontinued — - BRISTOL MYERS SQUIBBANDA 061605—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — - PFIZERANDA 061791—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued — - WYETH AYERSTANDA 061675—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Discontinued — EQ 500MG BASE TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
36 yr 10 mo ago
Most recent approval
36 yr 10 mo ago
All 15 applications were approved in 1990.
Brand (NDA) 00%
Generic (ANDA) 15100%
Erythromycin stearate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
